NCT01652352

Brief Summary

Researchers from the University of South Florida's Rehabilitation Engineering program are looking for volunteers to participate in a research study for experimental evaluation of wheelchair-mounted robotic arms (WMRAs). Participants will operate commercially available and developmental WMRAs in a physical test environment. The study will serve to identify desirable design features of WMRAs and input devices so that future production systems may further increase the quality of life of potential users. The study will also promote both the justification of prescribing WMRAs to enhance quality of life through the proposed standard testing method, and awareness for the emerging assistive robotics industry.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

11 months

First QC Date

September 13, 2010

Last Update Submit

July 27, 2012

Conditions

Keywords

DisabledDisabilityPower wheelchairWheelchairWheelchair mounted robotic armWMRAAssistiveAssistive robotAssistive roboticsRehabilitation robotRehabilitation engineeringRehabilitation robotics

Outcome Measures

Primary Outcomes (1)

  • Efficacy - Ease of Use

    In order to quantitatively evaluate the efficacy of each of up to six WMRAs, a survey will be presented to the participant at the conclusion of the final testing trial of each task of interest. The participant will be asked to rate the ease of performing the given task with the given WMRA and input device on a number ranking scale. The survey should be completed at the conclusion of testing trials for each task (the participant will be asked to perform up to four individual tasks).

    Efficacy in performing a given task with a given wheelchair- mounted robotic arm will be recorded after three (3) repetitions of the task have been completed. Testing should take no longer than 4 hours.

Secondary Outcomes (1)

  • Time of Completion

    Time of completion will be recorded after each testing trial. Testing should take no longer than 4 hours.

Study Arms (2)

Individuals with Disability

Power wheelchair-bound individuals with conditions which affect upper and lower body mobility, strength, or dexterity. Such conditions may include but are not limited to spinal cord injury, Multiple Sclerosis, Cerebral Palsy, or other conditions which affect overall mobility.

Able-Bodied Individuals

Those who possess no condition or injury resulting in loss of mobility.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Candidates will be recruited from University of South Florida facilities and through channels of normal operation of the Center for Assistive and Rehabilitation Robotic Technologies laboratory, its group members, and students. Included candidate sources are primary and specialist care facilities in the Tampa Bay area, affiliates of USF, CARRT, and the College of Engineering, contacts of said organizations, and the general community.

You may qualify if:

  • Be between the ages of 18 and 60
  • Have an injury or condition resulting in power wheelchair dependence
  • Consent to disclose pertinent medical information for purposes of determining level of mobility
  • Possess physical dexterity and capacity to operate the following devices:
  • button numeric keypad - dimensions: 3inch by 3inch square
  • Touch screen tablet PC - dimensions: 15inch (diagonal)
  • SpaceNavigator 3D joystick - movements: push, pull, lift, press, twist
  • Standard joystick - movements: push, pull
  • Chin joystick - movements: push, pull
  • Possess capacity to understand the objective of each task, including but not limited to turning on a light switch, opening a cabinet, moving a cup from a table top to the participant's mouth, and opening a door
  • Demonstrate the ability to understand, or become familiar with the basic function of both the input device and WMRA
  • Spend up to four (4) hours, at one time, in the laboratory located at:
  • Rehabilitation Robotics and Prosthetics Testbed (RRT) 13335 Laurel Drive Tampa, FL 33620
  • Consent to having a test platform temporarily attached to the participant's wheelchair. The attachment will use soft nylon straps and in no way inflict damage to the participant's property
  • Sign an informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Robotics and Prosthetics Testbed

Tampa, Florida, 33620, United States

Location

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesCerebral PalsyMultiple Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBrain Damage, ChronicBrain DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Rajiv Dubey, Ph.D.

    Major Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2010

First Posted

July 30, 2012

Study Start

August 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations